Trial · NCT00556712
A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT00556712, Phase 3, Completed, Hoffmann-La Roche; results first posted 2015-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT00556712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00556712
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT00556712
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 889 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- erlotinib [Tarceva], Placebo
- First posted
- 2007-11-12
- Last updated
- 2015-02-11
- Results first posted
- 2015-02-11
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) | Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Primary | PFS in All Participants (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology. |
| Primary | Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | 6 months | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Primary | Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Primary | PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008) | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Primary | Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008) | 6 months | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Secondary | Percentage of All Participants Who Died (Data Cutoff 12 January 2012) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months). | |
| Secondary | Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012) | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Secondary | Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | 1 year | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Secondary | Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) | Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | FAS; participants with PD prior to randomization were excluded from analysis. | percentage of participants | NUMBER |
| PRIMARY | PFS in All Participants (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | FAS; participants with PD prior to randomization were excluded from analysis. | weeks | MEDIAN |
| PRIMARY | Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | 6 months | FAS; participants with PD prior to randomization were excluded from analysis. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | FAS; only participants with EGFR IHC positive tumors were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of All Participants Who Died (Data Cutoff 12 January 2012) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months). | FAS | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012) | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) | FAS | months | MEDIAN |
| SECONDARY | Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | 1 year | FAS | percentage of participants | NUMBER |
| SECONDARY | Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) | FAS; only participants with EGFR IHC positive tumors were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) | FAS; only participants with EGFR IHC positive tumors were included in the analysis. | months | MEDIAN |
| SECONDARY | Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | 1 year | FAS | percentage of participants | NUMBER |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group530
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) | Placebo | 89.5 | percentage of participants | ||
| Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) | Erlotinib, 150 mg/Day | 79.9 | percentage of participants | ||
| PFS in All Participants (Data Cutoff 17 May 2008) | Placebo | 11.1 | 95% Confidence Interval 8.1 to 11.7 | weeks | |
| PFS in All Participants (Data Cutoff 17 May 2008) | Erlotinib, 150 mg/Day | 12.3 | 95% Confidence Interval 12.0 to 13.3 | weeks | |
| Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | Placebo | 15.0 | 95% Confidence Interval 12.0 to 19.0 | percentage of participants | |
| Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | Erlotinib, 150 mg/Day | 25.0 | 95% Confidence Interval 21.0 to 29.0 | percentage of participants | |
| Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) | Placebo | 89.4 | percentage of participants | ||
| Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) | Erlotinib, 150 mg/Day | 79.5 | percentage of participants | ||
| Percentage of All Participants Who Died (Data Cutoff 12 January 2012) | Placebo | 87.1 | percentage of participants | ||
| Percentage of All Participants Who Died (Data Cutoff 12 January 2012) | Erlotinib, 150 mg/Day | 82.0 | percentage of participants |
1 to 10 of 530Source ClinicalTrials.gov
See all 530 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 451 | |
| Overall Study | STARTED | Erlotinib, 150 Milligrams Per Day (mg/Day) | 438 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Erlotinib, 150 Milligrams Per Day (mg/Day) | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 451 | |
| Overall Study | NOT COMPLETED | Erlotinib, 150 Milligrams Per Day (mg/Day) | 438 |
Source ClinicalTrials.gov
Adverse events166
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 26 | 445 | |
| other | Rash | Skin and subcutaneous tissue disorders | Erlotinib, 150 mg/Day | 211 | 433 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 12 | 445 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Erlotinib, 150 mg/Day | 32 | 433 | |
| other | Acne | Skin and subcutaneous tissue disorders | Placebo | 0 | 445 | |
| other | Acne | Skin and subcutaneous tissue disorders | Erlotinib, 150 mg/Day | 27 | 433 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 20 | 445 | |
| other | Diarrhoea | Gastrointestinal disorders | Erlotinib, 150 mg/Day | 87 | 433 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 27 | 445 | |
| other | Nausea | Gastrointestinal disorders | Erlotinib, 150 mg/Day | 33 | 433 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Erlotinib, 150 mg/Day | ||
| Total, other adverse events | Placebo | 152 | 445 |
| Total, other adverse events | Erlotinib, 150 mg/Day | 283 | 433 |
| Total, serious adverse events | Placebo | 34 | 445 |
| Total, serious adverse events | Erlotinib, 150 mg/Day | 49 | 433 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20493771 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Erlotinib, 150 mg/Day vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00556712
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